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1 Dako GenPoint HPV Biotinylated DNA Probe for In Situ Hybridization pour hybridation in situ zur In situ Hybridisierung English Code Y1443 Intended use For In Vitro Diagnostic Use. GenPoint HPV Biotinylated DNA probe is intended for use in in situ hybridization staining procedure using Dako GenPoint Detection System (code K0620) for the detection of human papillomavirus (HPV). Summary and explanation HPV has been found in epithelial cells of several different organs, including skin and genital tract. 1 HPV is found in the nucleus and can be of either episomal (free viruses) or integrated form. 2 Reagent provided GenPoint HPV Probe contains HPV genomic clones in the form of double-stranded fragments of 500 base pairs or less (biotinylated* and unlabeled), and multiple biotinylated oligonucleotides from 25 to 40 bases in length. The probe is ready-to-use and is provided in 1.0 ml of in situ hybridization solution (0.3 mol/l NaCl, 50% formamide in buffer). The probe is optimized with the GenPoint Detection System (code K0620). *U.S. Patent 4,599,303 sub-licensed from Schleicher & Schuell, Inc. Materials required, but not supplied Refer to the GenPoint detection system instructions. Specificity GenPoint HPV Biotinylated DNA probe has been found to react with HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68 on formalin-fixed paraffin embedded cervical tissues and/or cells by in situ hybridization. Precautions 1. For professional users. 2. Minimize microbial contamination of reagents or increase in nonspecific staining may occur. 3. As with any product derived from biological sources, proper handling procedures should be used. 4. As a general rule, persons under 18 years of age are not allowed to work with this product. Users must be carefully instructed in the proper procedure, the dangerous properties of the product and the necessary safety instructions. 5. Wear appropriate Personal Protective Equipment to avoid contact with eyes and skin. 6. Unused solution should be disposed of according to local, State and Federal regulations. 7. Safety Data Sheet available for professional users on request. Risk and Safety statements GenPoint HPV Biotinylated DNA Probe: 30-60% Formamide / Hazard Symbol: Toxic R61 May cause harm to the unborn child. S45 In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible). S53 Avoid exposure - obtain special instructions before use S60 This material and/or its container must be disposed of as hazardous waste. Restricted to professional users. Storage Store at 2 8 C. Specimen preparation Paraffin Sections GenPoint HPV Biotinylated DNA probe can be used on formalin-fixed, paraffin-embedded tissue sections. For greater adherence of tissue sections to glass slides, the use of Silanized Slides (code S3003) is recommended. The deparaffinized tissue sections require pretreatment to provide the probe access to target nucleic acid sequences. This can be achieved with an incubation of the tissue sections in 0.8% Pepsin (code S3002, dissolve packet in 250 ml 0.2N Hydrochloric acid) at 37 C for 5 10 minutes. Following digestion, sections are rinsed in several changes of deionized water, then immersed in 0.3% H 2O 2 in methanol for 20 minutes, and rinsed with several changes of deionized water. ( ) EFG_002p. 1/5

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